Sarclisa Gains EU Approval for Newly Diagnosed Multiple Myeloma in Transplant-Eligible Patients
Friday, July 25, 2025
Sanofi has received approval from the European Commission for the use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as an induction treatment for adults newly diagnosed with multiple myeloma (NDMM) who are eligible for autologous stem cell transplantation.
The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), issued on 19 June 2025.
This authorisation is based on findings from Part 1 of the GMMG-HD7 Phase 3 study, a two-part, randomised, multicentre trial carried out by the German-speaking Myeloma Multicenter Group (GMMG) in collaboration with Sanofi. The study assessed the benefits of adding Sarclisa to the standard VRd regimen before transplantation. The data showed that Sarclisa-VRd led to a faster and deeper treatment response compared to VRd alone, with a significantly higher rate of minimal residual disease (MRD) negativity at the end of the 18-week induction phase.
Further analysis also confirmed an improvement in progression-free survival (PFS) for those receiving Sarclisa-VRd during the induction phase, regardless of subsequent maintenance therapy. More than half (53.1%) of the patients treated with Sarclisa-VRd remained MRD-negative from post-induction to post-transplant, compared to 38% in the control group, indicating a consistent and sustained benefit.
These results support the potential role of Sarclisa as part of first-line treatment for transplant-eligible patients. Part 2 of the study, which is evaluating maintenance therapy with Sarclisa and lenalidomide versus lenalidomide alone, is ongoing and further results are expected.
The GMMG-HD7 trial included 662 newly diagnosed, transplant-eligible patients from 67 centres in Germany. In the induction phase, all patients received three 42-day cycles of VRd, while Sarclisa was administered to one of the arms. After induction, all participants underwent autologous stem cell transplantation. In the maintenance phase, patients were rerandomised to receive either Sarclisa plus lenalidomide or lenalidomide alone.
Sarclisa was administered intravenously at a dose of 10 mg/kg weekly during the first cycle, followed by biweekly dosing for the remainder of the induction period. The study's main goals include MRD negativity after induction (Part 1) and PFS following the post-transplant maintenance phase (Part 2). Secondary objectives include response rates, overall survival, and safety.
With this latest approval, Sarclisa now has four authorised indications globally, including two for first-line treatment, highlighting its growing role in multiple myeloma care and Sanofi’s ongoing efforts to improve patient outcomes.
Source: globenewswire.com
